Sleep apnea machine maker Phillips formally entered into a consent decree stemming from recalled machines Tuesday. The ...
The settlement comes nearly three years after the company acknowledged that an industrial foam fitted inside its machines ...
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines ...
After a 2023 inspection, the FDA found three unreported field corrections related to CT machines and 19 other recalls of radiology devices.
CEO Roy Jakobs in January noted on average it takes five to seven years to comply with consent decrees in the medical ...
Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep ...
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
According to an announcement posted by the Consumer Product Safety Commission, the recall applies to Tide Pods, Gain Flings, ...
ResMed (NYSE: RMD) shares ticked up after hours on third-quarter results that came in ahead of the consensus forecast.
Philips Respironics will retain independent experts to review various aspects of the recall remediation ... to be used in accordance with the instructions for use. Roy Jakobs, CEO at Philips said: ...
Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical ...
Koninklijke Philips NV (NYSE:PHG) said it reached a final agreement with the U.S. Justice Department and FDA regarding a ...